MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC® PARAPAC® VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	P200DNUS
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that parts of the disposable breathing circuit outlet are missing.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection confirmed that the outlet connector on the main unit was missing.It is thought that the outlet connector has become loose due to long-term use of the device.The outlet connector was attached to the main body.There is no repair history in the past for this device.The reported problem is not related to previous icu medical repairs.

• Brand Name: PNEUPAC® PARAPAC® VENTILATOR
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18861314
• Report Number: 3012307300-2024-01205
• Device Sequence Number: 8239800
• Product Code: BTL
• UDI-Device Identifier: 35019315072738
• UDI-Public: (01)35019315072738(11)140114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P200DNUS
• Device Catalogue Number: P200DNJPAMBJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/24/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown